Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19A Randomized Clinical Trial
Spinner et al.
, Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19A..
, JAMA, doi:10.1001/jama.2020.16349
Late stage (median 8 days from symptom onset) RCT 584 patients with moderate COVID-19 showing (non-statistically significant) lower mortality.
5-day remdesivir had significantly higher odds of a better clinical status distribution on the 7-point ordinal scale, odds ratio OR 1.65, p
= 0.02. The difference for 10-day remdesivir was not statistically significant, p
=0.18.[Gérard, Wu, Zhou]
show significantly increased risk of acute kidney injury with remdesivir.
5 or 10 day remdesivir vs. control 28 day mortality, 34.9% lower, RR 0.65, p = 0.50, treatment 5 of 384 (1.3%), control 4 of 200 (2.0%), NNT 143.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Spinner et al., 21 Aug 2020, Randomized Controlled Trial, multiple countries, peer-reviewed, 30 authors, average treatment delay 8.0 days.
JAMA | Original Investigation
Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days
in Patients With Moderate COVID-19
A Randomized Clinical Trial
Christoph D. Spinner, MD; Robert L. Gottlieb, MD, PhD; Gerard J. Criner, MD; José Ramón Arribas López, MD; Anna Maria Cattelan, MD;
Alex Soriano Viladomiu, MD; Onyema Ogbuagu, MD; Prashant Malhotra, MD; Kathleen M. Mullane, DO; Antonella Castagna, MD;
Louis Yi Ann Chai, MD; Meta Roestenberg, MD; Owen Tak Yin Tsang, MD; Enos Bernasconi, MD; Paul Le Turnier, MD; Shan-Chwen Chang, MD;
Devi SenGupta, MD; Robert H. Hyland, DPhil; Anu O. Osinusi, MD; Huyen Cao, MD; Christiana Blair, MS; Hongyuan Wang, PhD;
Anuj Gaggar, MD, PhD; Diana M. Brainard, MD; Mark J. McPhail, MD; Sanjay Bhagani, MD; Mi Young Ahn, MD; Arun J. Sanyal, MD;
Gregory Huhn, MD; Francisco M. Marty, MD; for the GS-US-540-5774 Investigators
IMPORTANCE Remdesivir demonstrated clinical benefit in a placebo-controlled trial in
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patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients
with moderate disease is unknown.
OBJECTIVE To determine the efficacy of 5 or 10 days of remdesivir treatment compared
with standard care on clinical status on day 11 after initiation of treatment.
DESIGN, SETTING, AND PARTICIPANTS Randomized, open-label trial of hospitalized patients
with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and
moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%)
enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe,
and Asia. The date of final follow-up was May 20, 2020.
INTERVENTIONS Patients were randomized in a 1:1:1 ratio to receive a 10-day course of
remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200).
Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d.
MAIN OUTCOMES AND MEASURES The primary end point was clinical status on day 11
on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7).
Differences between remdesivir treatment groups and standard care were calculated using
proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates
difference in clinical status distribution toward category 7 for the remdesivir group vs the
standard care group.
RESULTS Among 596 patients who were randomized, 584 began the study and received
remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years;
227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes),
and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the
5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11,
patients in the 5-day remdesivir group had statistically significantly higher odds of a better
clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI,
1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir
and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).
By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day
remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia
(6% vs 2%), and headache (5% vs 3%) were more frequent among..
is less effective
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